Sufentanil Citrate: Sufentanil citrate administered via peripheral intravenous syringe pump during general anesthesia induction. Fixed weight-based total dose within each age sub-cohort; infusion time varies according to biased-coin up-and-down sequential rules.
Study summary
This single-center, prospective biased coin up-and-down sequential study aims to determine the 90% effective infusion time (ET90) of sufentanil to prevent sufentanil-induced cough (SIC) during the induction phase of general anesthesia in adults undergoing endotracheal intubation. Two age cohorts are studied separately: younger adults (\<65 years) and older adults (≥65 years). The trial does not test superiority or between-group differences as the primary objective.
All participants receive sufentanil via a peripheral intravenous pump. The total sufentanil dose is fixed within each age cohort (young: 0.40 μg/kg; elderly: 0.30 μg/kg), while the pump injection time is adjusted using the biased coin up-and-down allocation method. SIC success is defined as no audible cough within a prespecified observation window from the start of the infusion until 2 minutes after infusion ends.
The primary outcome is the ET90 of sufentanil and its 95% confidence interval for each age cohort, estimated using centered isotonic regression with bootstrap confidence intervals. Approximately 120 patients will be screened to obtain at least 54 evaluable participants per cohort.
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria:
* American Society of Anesthesiologists (ASA) physical status I-III
* Aged ≥18 ears old
* Scheduled for elective surgery requiring general anesthesia with tracheal intubation
Exclusion Criteria:
* Resting vital signs upon operating-room arrival: systolic blood pressure ≥160 mmHg, or diastolic blood pressure ≥100 mmHg, or heart rate ≥110 beats per minute.
* Anticipated difficult airway, requirement for rapid-sequence induction, or emergency surgery.
* Chronic cough, asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis, active pulmonary disease, or upper respiratory tract infection within the preceding 2 weeks.
* Regular opioid use for more than 2 weeks within 6 months before surgery; or recent use of antitussive agents or other medications that may alter the cough reflex.
* Known history of allergy to study drug (sufentanil citrate).
* Pregnancy, lactation, psychiatric disorders, or individuals unable to communicate appropriately.
Primary outcome measure(s)
90% effective infusion time (ET90) of sufentanil for preventing sufentanil-induced cough (SIC) — From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period) ET90 is defined as the shortest sufentanil infusion time achieving no SIC in 90% of participants, estimated separately for younger adults (\<65 years) and older adults (≥65 years) using centered isotonic regression with bootstrap 95% confidence intervals. SIC is defined as any audible cough within the predefined observation window.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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